FDA.reportPublic FDA data

Ampicillin and Sulbactam

Product NDC
83634-109
11-digit product format
836340109
Labeler code
83634
Product ID
83634-109_defc86ea-aea6-4978-b547-2473933197ef
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ampicillin and sulbactam
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Avenacy, LLC
Application
ANDA065222
Marketing category
ANDA
Marketing start
2025-02-01
Substance
AMPICILLIN SODIUM; SULBACTAM SODIUM
Active strength
1; .5 g/1; g/1
Pharmacologic classes
Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ampicillin and Sulbactam
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMPICILLIN SODIUM1 g/1
SULBACTAM SODIUM.5 g/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJFN36L5S8K, DKQ4T82YE6
Rxcui1659592, 1659598

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fd9d6ee0-43ae-43c7-aa52-3d5a936186d6Product name120250722
1f6437d4-fe6e-4912-889c-84576c1da4d8Product name120231019
4fe9b92f-7dcd-4058-8def-e75f4dcd5ab3Product name220160201
c9385d77-2af7-47a4-bc97-1127e71caf9bProduct name320160201
05b6b9ae-4ba4-27ee-4c8c-f72b41de3815Product name520151207
b353113e-7b3d-4b1f-a286-b96a3a5eac85Product name320151026
8c59be9b-72b0-49e8-b7ef-1a80c10599deProduct name320150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83634-109-20Ampicillin and Sulbactam10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION102
83634-109-41Ampicillin and Sulbactam1 in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, FOR SOLUTION12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83634-109AMPICILLIN AND SULBACTAM INJECTION, POWDER, FOR SOLUTION [AVENACY INC.]1Current NDC, 2 package rows20250201_4446d4c8-056d-4bc3-8f58-21255b063398.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1659592ampicillin / sulbactam 1.5 GM InjectionPSN4446d4c8-056d-4bc3-8f58-21255b0633982
1659598ampicillin / sulbactam 3 GM InjectionPSN4446d4c8-056d-4bc3-8f58-21255b0633982
1659592ampicillin 1000 MG / sulbactam 500 MG InjectionSCD4446d4c8-056d-4bc3-8f58-21255b0633982
1659598ampicillin 2000 MG / sulbactam 1000 MG InjectionSCD4446d4c8-056d-4bc3-8f58-21255b0633982
1659592ampicillin (as ampicillin sodium) 1 GM / sulbactam (as sulbactam sodium) 0.5 GM InjectionSY4446d4c8-056d-4bc3-8f58-21255b0633982
1659598ampicillin (as ampicillin sodium) 2 GM / sulbactam (as sulbactam sodium) 1 GM InjectionSY4446d4c8-056d-4bc3-8f58-21255b0633982
1659592ampicillin 1 GM / sulbactam 0.5 GM InjectionSY4446d4c8-056d-4bc3-8f58-21255b0633982
1659598ampicillin 2 GM / sulbactam 1 GM InjectionSY4446d4c8-056d-4bc3-8f58-21255b0633982

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
83634-109-208363401092010 VIAL, SINGLE-DOSE in 1 CARTON (83634-109-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (83634-109-41) 2025-04-25NoNoCurrent
83634-109-41836340109411 in 1 VIAL, SINGLE-DOSEHistorical